Due to growing concerns over the supply of immunoglobulin products, the Food and Drug Administration (FDA) has extended the shelf life of 42 existing lots currently in the distribution chain and all future lots of cutaquig® (immune globulin, subcutaneous [human]-hipp 16.5% solution; Octapharma USA) from 24 to 36 months when stored at 2°C to 8°C (36°F to 46°F).
The new expiration date for cutaquig is valid for 42 existing lots that were manufactured and distributed in 2019 and 2020; the complete list of affected cutaquig lots can be found here. Future lots will be labeled according to the new extended shelf life. The 6-month shelf life of cutaquig when stored at room temperature up to +25°C (77°F) remains unchanged.
“As the supply of immunoglobulin products faces challenges in the near future, the longer shelf life of cutaquig is an important consideration,” said Octapharma USA President Flemming Nielsen. “Octapharma has increased its production of immunoglobulin products by more than 45% over the last year so we have strong supply to meet patient needs.”
Cutaquig is a ready-to-use immune globulin solution for subcutaneous infusion indicated for the treatment of primary humoral immunodeficiency in adults. The product is supplied in 1g, 1.65g, 2g, 3.3g, 4g, or 8g single-use vials.
For more information visit octapharmausa.com.
FDA extends shelf life of Octapharma’s cutaquig® 16.5% for adult PI patients. [press release]. Paramus, NJ: Octapharma USA; January 5, 2021.